# K192586: LIAISON® Folate

- Pathway: 510(k) (Traditional)
- Applicant: DiaSorin, Inc.
- Decided: May 6, 2020 after 230 days
- Product code: CGN (Acid, Folic, Radioimmunoassay)
- Device class: 2
- Regulation: 21 CFR 862.1295
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K972232 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092740: Architect Folate Reagents, Architect Folate Calibrators, and Architect Folate Controls, Models 1P74, 1P74, 1P74, Abbott Laboratories (2010) Summary page 4.

## Indications for use
The DiaSorin LIAISON® Folate assay uses chemiluminescent immunoassay (CLIA) technology for the quantitative determination of Folic acid in human serum. Folic acid measurements are used in the diagnosis and treatment of anemias. Assay results should be used in conjunction with other clinical or laboratory data to assist the clinician in making individual patient management decisions. The assay must be performed on the LIAISON® XL Analyzer.

Source page: https://510kreport.com/device/K192586
Methodology: https://510kreport.com/methodology